Draft Policy Recommendations Self-directed Interactive Review
Category 5: Participants - Insurance
These policies are designed to ensure that lack of insurance or coverage for clinical trials
is not a barrier to participation.
Section 1: Insurance Coverage - CMS Coverage
Background:
Because costs associated with clinical trials are often a concern for participants,
the existence of insurance coverage for clinical trials may act as a barrier to participation
in clinical trials. For example, a study of NCI-sponsored cancer treatment trials found
that uninsured patients represented only 5.4% of all clinical trial participants.1
Even when participants have insurance, some private third-party payers do not
cover the full costs associated with participating in the clinical trial.2 Though few studies
have addressed the question outside of the context of cancer, the cancer studies have
shown that the cost for a patient to take part in a clinical trial is not necessarily any more
expensive than it is for the patient to receive standard care.3
Moreover, as is the case in general with barriers to clinical trials, the problems of
cost and out-of-pocket expenses may affect underrepresented populations with greater
frequency or intensity than populations already proportionately represented in clinical
trials. As such, enhancing information flow regarding the extent of insurance coverage
for clinical trials is integral to ameliorating disparities in clinical trials.
The cost to conduct the clinical trial is not adequately reimbursed on the public
side to support the clinical trial. Even if people do have insurance coverage, this issue
will still hamper accrual. Furthermore, the seemingly obvious solution - to enact
mandates that would require insurers to reimburse for costs associated with clinical trials
- is flawed for several reasons. First, any state mandate would be preempted and hence
inapplicable to any ERISA (self-insured) plan. Thus, any such mandate would have a limited impact in
ameliorating the problem. Second, imposing coverage mandates tends to frustrate
insurers' ability to assess risk, which may result in higher premiums that would have a
disproportionate impact on many of the same underrepresented populations who face disparities in clinical trials. For these and similar reasons, several advocacy groups
recently abandoned their efforts to advocate for such mandates, and the EDICT Team
joins them in believing that other policy approaches are more fruitful.
Policy Recommendation 1: Medicare Coverage
Congress expressly authorize CMS to adopt policies that link coverage of clinical trials to
sponsors' and research teams' certification that the protocol contains specific plans and
demonstrated capacity to ensure appropriate inclusion and representation of populations
underrepresented in clinical trials.
Rationale behind this recommendation:
In the summer of 2007, CMS announced several Reconsiderations of its 2000 Clinical Trials Policy. These Reconsiderations proposed adding a self-certification process in which clinical trials sponsors/research teams would be required to satisfy in order for benefits to extend to participants in clinical trials sponsored or conducted by them. One of the items in the self-certification process would require entities to demonstrate a plan for recruiting and retaining members of underrepresented populations in clinical trials. The EDICT Team was and remains a strong supporter of the proposed changes. Though CMS ultimately decided to maintain the status quo for the time being, this recommendation reflects the EDICT Team's continuing belief that tying Medicare coverage for clinical trials to researchers' demonstrated and specific plans for ensuring appropriate inclusion is integral to eliminating disparities in clinical trials. Moreover, if Congress were to expressly authorize CMS to adopt such policies, that would reaffirm the congressional commitment to appropriate inclusion embodied in the Revitalization Act.
Further details on the proposed Reconsiderations, including copies of all public comments issued by the EDICT Team on this issue, are available on the EDICT website.4
Policy Maker Focus: U.S. Congress
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Section 2: Insurance Coverage - Employers
Background: same as for previous recommendation
Policy Recommendation 1: Employers & Coverage
Because the lack of insurance coverage is a significant barrier to increase the opportunity
for members of underrepresented populations to participate in clinical trials, the EDICT Team
recommends that business groups such as the National Business Group on Health
(NBGH) and the CEO Roundtable on Cancer:
a) request that their member companies provide coverage for clinical trials in
their healthcare plans; and
b) encourage their member companies to document the extent of benefits and
communicate those benefits to employees with regard to participation in
clinical trials.
Rationale behind this recommendation:
Given the complexity of health insurance coverage in general, there is reason to
suspect that even people who do have insurance coverage may not know whether their
policies include benefits for clinical trials. Thus, the policy recommendation for
employers (a), urges trade associations like the National Business Group on Health, and the
CEO Roundtable to encourage member companies to clarify the extent
of coverage for subscribers for benefits connected to clinical trials. Policy
recommendation (b) for employers follows up by urging the same associations to
encourage greater transparency between employers and employees regarding the extent
of coverage.
Policy Maker Focus: Business groups and associations, employers providing insurance
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Section 3: Insurance Coverage
Background: same as for previous recommendation
Policy Recommendation 1: Insurers/Employee Benefits Trade Associations
Because the lack of insurance coverage is a significant barrier to increase the
opportunity for members of underrepresented populations to participate in clinical trials, the
EDICT Team recommends that health insurance or employee benefits related trade or
business groups such as NBGH, Society for Human Resource Management (SHRM),
America's Health Insurance Plans (AHIP), CEO Roundtable on Cancer and the NBGH
request that their member companies enhance benefit managers' knowledge regarding
coverage for clinical trials.
Rationale behind this recommendation:
Because insurance benefit managers may lack knowledge of the scope of clinical
trials and the extent to which coverage is extended to subscribers, the policy
recommendation for insurance companies urges the relevant trade associations to
encourage its member companies to take action intended to enhance benefit managers'
knowledge regarding coverage for clinical trials.
Policy Maker Focus: Insurance trade groups, insurance companies and employee
benefits related trade groups
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Section 4: CMS Reporting State Coverage
Background: same as for previous recommendation
Policy Recommendation 1: CMS Reporting
Because the lack of insurance coverage is a significant barrier to increase the
opportunity for members of underrepresented populations to participate in clinical trials, the
EDICT Team recommends that the Centers for Medicare and Medicaid Services (CMS)
adopts policies that:
a) develop a reporting mechanism to gather and disseminate information on
state coverage for clinical trials in Medicaid and SCHIP programs; and
b) encourage state Medicaid and SCHIP programs to adopt policies that are
consistent with the policies of Medicare clinical trials coverage.
Rationale behind this recommendation:
Because Medicaid varies from state to state, and also because CMS is a prime
mover in shaping reimbursement policy in both public and private markets, the policy
recommendations on CMS reporting on state coverage urges CMS to adopt policy
designed to increase collective understanding on Medicaid coverage for clinical trials.
CMS's national coverage determination as to Clinical Trials Policy has already garnered
significant attention regarding the need for Medicare reimbursement of costs associated
with clinical trials,5 and features of Medicaid coverage are an important complement.
Unfortunately, no comprehensive data exists on the latter, and CMS is in the best position
to make the collection and analysis of such data a priority.
Policy Maker Focus: CMS
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Section 5: Mandates for Education by States and CMS
Background:
Two of the primary barriers to increasing participation in clinical trials are
mistrust and lack of awareness of clinical trials. Such mistrust is particularly prevalent
among underrepresented populations, many of which, sadly, have sound historical reasons for
such mistrust. As to lack of awareness, one survey found that 80% of respondents were
unaware that they were eligible to participate in a clinical trial related to their illness.6
One possible means of ameliorating both mistrust and lack of awareness is
enhancing educational opportunities regarding clinical trials for the public.
Notwithstanding the legitimate basis for some underrepresented populations' mistrust of
clinical trials, many persons may also harbor various fears and misconceptions regarding
clinical trials.7 These fears could be assuaged with effective education. Moreover, the
obvious remedy for the general lack of awareness of clinical trials is to increase such
awareness via enhanced education.
While almost half of all states require that insurers cover the costs associated with
clinical trials, and CMS announced in 2000 that it would reimburse such costs, there is no
concomitant mandate regarding public education of clinical trials.
Policy Recommendation 1: State Education of Beneficiaries
Because educating the public on the clinical trial process is integral to ameliorating
disparities in clinical trials, the EDICT Team recommends that
(1) all states that mandate insurance coverage for costs associated with clinical trials
should also mandate these companies provide to each member
(a) educational materials; and
(b) information about the benefit separate from any other communication (i.e.,
a policy coverage book).
Rationale behind this recommendation:
Both federal and state governments have recognized the importance of ensuring
insurance coverage for clinical trials. Approximately 20 states have enacted laws
requiring insurers to cover reasonable costs associated with clinical trials. Similarly, the
Medicare clinical trials policy has mandated such coverage as to Medicare since 2000,
and CMS expressly considered expanding coverage in its 2007 reconsideration of its
Clinical Trials Policy.
Nevertheless, neither the relevant state laws nor the Medicare clinical trials policy
contains any express requirements regarding education for the respective beneficiaries.
This is significant because patients' lack of awareness regarding clinical trials is a
significant barrier both to general participation in clinical trials and to members of
underrepresented populations' participation.
Accordingly, this policy recommendation fills an important hole in state policies
by requiring educational materials be provided to relevant beneficiaries. Attaching the
educational requirements to pre-existing mandates will ideally ease implementation and
enhance impact, particularly as applied to the Medicare clinical trials policy.
Policy Maker Focus: States mandating insurance coverage of clinical trials.
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Policy Recommendation 2: Education of Medicare/Medicaid
Beneficiaries
Because educating the public on the clinical trial process is integral to
ameliorating disparities in clinical trials, the EDICT Team recommends that:
(2) CMS adopt policy designed to ensure that all Medicare beneficiaries receive
(a) educational materials; and
(b) information about the benefit separate from any other communication (i.e.,
a policy coverage book).
Rationale behind this recommendation:
Both federal and state governments have recognized the importance of ensuring
insurance coverage for clinical trials. Approximately 20 states have enacted laws
requiring insurers to cover reasonable costs associated with clinical trials. Similarly, the
Medicare clinical trials policy has mandated such coverage as to Medicare since 2000,
and CMS expressly considered expanding coverage in its 2007 reconsideration of its
Clinical Trials Policy.
Nevertheless, neither the relevant state laws nor the Medicare clinical trials policy
contains any express requirements regarding education for the respective beneficiaries.
This is significant because patients' lack of awareness regarding clinical trials is a
significant barrier both to general participation in clinical trials and to members of
underrepresented populations' participation.
Accordingly, this policy recommendation fills an important hole in state policies
by requiring educational materials be provided to relevant beneficiaries. Attaching the
educational requirements to pre-existing mandates will ideally ease implementation and
enhance impact, particularly as applied to the Medicare clinical trials policy.
Policy Maker Focus: CMS.
click here to submit your feedback on this policy recommendation
1 Sateren, W.B., et al., How sociodemographics, presence of oncology specialists, and hospital cancer
programs affect accrual to cancer treatment trials. Journal of Clinical Oncology, 2002 20(8): p. 2109-17.
2 Goldman, D.P., et al., Incremental treatment costs in National Cancer Institute-sponsored clinical trials.
Journal of the American Medical Association, 2003. 289(22): p. 2970-2977.
3 Ibid.; see also Brown, M.L., Cancer patient care in clinical trials sponsored by the National Cancer
Institute: what does it cost? Journal of the National Cancer Institute, 1999. 91(10): p. 818-19; Fireman,
B.H., et al., Cost of care for patients in cancer clinical trials. Journal of the National Cancer Institute,
1999. 91(10): p. 847-53.
4 See EDICT Project, www.bcm.edu/edict/.
5 See, e.g., CCH Healthcare Compliance, "Revised NCD Expands Access to Clinical Trials," available at
http://health.cch.com/news/healthcare-compliance/072507a.asp (last visited August 13, 2007).
6 National Cancer Institute, "Doctors, Patients Face Different Barriers to Clinical Trials," available at
http://www.cancer.gov/clinicaltrials/developments/doctors-barriers0401 (last accessed August 13, 2007).
7 Ibid.
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